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Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01155323
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : October 4, 2011
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: etafilcon A
Device: omafilcon A
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etafilcon A/Omafilcon A Omafilcon A/Etafilcon A
Hide Arm/Group Description etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second. omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
Period Title: First Intervention
Started 60 58
Completed 59 57
Not Completed 1 1
Reason Not Completed
exclusion criteria             1             1
Period Title: Second Intervention
Started 59 57
Completed 58 56
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Total Number of Participants
Hide Arm/Group Description This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants
25.3  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Female
80
  70.8%
Male
33
  29.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Singapore Number Analyzed 113 participants
113
1.Primary Outcome
Title Subjective Rating of Comfort
Hide Description This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.33  (0.09) 3.32  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.21 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments Mean difference is calculated as etafilcon A minus omafilcon A.
2.Primary Outcome
Title Vision Quality
Hide Description This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.53  (0.08) 3.50  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin = -0.50
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.19 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The mean difference is calculated as etafilcon A minus omafilcon A.
3.Primary Outcome
Title Subjective Rating of Handling
Hide Description This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.48  (0.09) 3.48  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin = -0.50
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.22 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The mean difference is calculated as etafilcon A minus omafilcon A.
4.Primary Outcome
Title Corneal Staining
Hide Description Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.07  (0.01) 0.09  (0.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Margin = +/-0.50
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.03 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments The mean difference is calculated as etafilcon A minus omafilcon A.
5.Primary Outcome
Title Subjective Rating of Quality Perceptions
Hide Description This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame after 1 week of lens wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.51  (0.08) 3.44  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin = -0.50
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.15 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The mean difference is calculated as etafilcon A minus omafilcon A.
6.Primary Outcome
Title Limbal Hyperemia
Hide Description This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Time Frame after 1 week of wear
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population represents subjects that completed the study per protocol.
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description:
soft contact lens replaced daily, worn for one week.
soft contact lens replaced daily, worn for one week.
Overall Number of Participants Analyzed 113 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.51  (0.02) 0.48  (0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etafilcon A, Omafilcon A
Comments The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Margin = +/- 0.50
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.01 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments The mean difference is calculated as etafilcon A minus omafilcon A.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etafilcon A Omafilcon A
Hide Arm/Group Description soft contact lens replaced daily, worn for one week. soft contact lens replaced daily, worn for one week.
All-Cause Mortality
Etafilcon A Omafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Etafilcon A Omafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/116 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etafilcon A Omafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/116 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wakana Katabami
Organization: Johnson and Johnson K.K.
Phone: 81-34411-8040 ext 22025
EMail: wkatabam@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01155323    
Other Study ID Numbers: CR-0926
DISP-523 ( Other Identifier: Visioncare Research Ltd )
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: August 29, 2011
Results First Posted: October 4, 2011
Last Update Posted: June 19, 2018